Varenicline (Includes Varenicline) ↔ Neuropsychiatric Events

Serious neuropsychiatric events including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking varenicline. Caution is recommended and patients should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide.

Moderate

Varenicline (Includes Varenicline) ↔ Alcoholism

Moderate Potential Hazard, Moderate plausibility

Applies to: Acute Alcohol Intoxication

Varenicline can enhance the response to alcohol and patients may experience increased intoxicating effects. In patients who may use alcohol excessively, it should be kept in mind that the potentiation may increase the danger associated with the use of alcohol. Advise patients to reduce the amount of alcohol they consume and to use caution driving or operating machinery or engaging in other potentially hazardous activities while taking varenicline until they know how this agent may affect them.

Moderate

Varenicline (Includes Varenicline) ↔ Cv Disease

There have been reports of cardiovascular events, including ischemic and hemorrhagic events in patients taking varenicline. Caution is recommended when prescribing this agent. Patients should be monitored for signs of new or worsening symptoms of cardiovascular disease and appropriate therapy should be instituted according to medical guidelines.

Moderate

Varenicline (Includes Varenicline) ↔ Renal Impairment

Moderate Potential Hazard, Moderate plausibility

Applies to: Renal Dysfunction

Varenicline is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Dose reduction is not required in patients with mild to moderate renal impairment. Dosage adjustment is needed in patients with severe renal impairment, and those with end-stage renal disease undergoing hemodialysis. Varenicline has been shown to be dialyzed in patients with end-stage renal disease. Monitoring of renal function is recommended.

Moderate

Varenicline (Includes Varenicline) ↔ Seizures

Moderate Potential Hazard, Moderate plausibility

Applies to: Seizures

Seizures have been reported with varenicline therapy. Therapy with this drug should be administered with caution and monitoring is recommended in patients with a history of seizures or other factors that can lower the seizure threshold.

Do not stop taking any medications without consulting your healthcare provider.

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